Centers for Education and Research on Therapeutics (CERTs) (U19)

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A. Renewal or New Applications

Question A1: Can currently funded CERTs institutions (such as a Research Center or Coordinating Center) submit a renewal application to RFA-HS-11-004?

Answer A1: Renewal applications are not permitted to RFA-HS-11-004. This is a new FOA, with a new mechanism of support, new requirements, and updated research objectives. All applications to RFA-HS-11-004 will be processed as new applications. Current CERTs grantees must submit a new application and follow the referenced PHS 398 application form instructions in the RFA.

RFA-HS-11-004 erroneously states that renewal applications are permitted. In addition to posting this correction here as a Frequently Asked Question (FAQ), AHRQ is disseminating a correction through the National Institutes of Health (NIH) Guide for Grants and Contracts (available at http://grants.nih.gov/grants/guide/notice-files/NOT-HS-11-012.html).

Question A2: Will new applications be accepted or is this RFA primarily intended to support currently funded CERTs Research Centers?

Answer A2: All eligible institutions, regardless of whether they have been previously or are currently funded as CERTs or not, are encouraged to apply to RFA-HS-11-004.

Question A3: Will this funding opportunity be re-issued in 2012?

Answer A3: The CERTs RFAs are competed on a periodic cycle rather than a continuous basis. The most recent open competition prior to this one was in September 2006. AHRQ cannot comment on the likelihood or timing of any future competitions.

B. Number and Nature of Expected Awards

Question B1: Will this FOA expand the current number of CERTs or will it maintain the same total number after the awards are made?

Answer B1: Funding for all of the 14 current CERTs Research Centers will end during calendar year 2011, and they must submit new applications as per question A1. AHRQ intends to commit $5.1 million in fiscal year 2011 to fund up to six awards, ranging from $800,000 to $1,000,000 in annual total costs. If funds become available, AHRQ reserves the right to fund additional applications.

Question B2: The RFA states that one center that focuses on patient safety will be funded. Does this mean at least one center or no more than one center?

Answer B2: Patient safety funding will support at least one CERTs Research Center.

Question B3: Please clarify the earliest possible start date, as the information in Sections IV and V of the FOA appear to lead to different possible start dates.

Answer B3: The information in Section IV applies to this specific FOA, so the earliest possible start date would be within fiscal year 2011, which ends September 30, 2011. Section V includes general FOA timelines, which do not apply in this case. We apologize for the discrepancy and confusion.

C. Eligibility/Who Can Apply

Question C1: Do applications need to come from an already established CERTs site?

Answer C1: No. There is no requirement that an application must come from an already established CERTs site. All eligible institutions, regardless of whether they have been previously or are currently funded as CERTs or not, are encouraged to apply to RFA-HS-11-004. This is a new FOA and not a re-issue. All current CERTs institutions will have their funding end during calendar year 2011.

Question C2: Is this RFA limited to academic medical centers or may other organizations apply?

Answer C2: Please review the institutional eligibility criteria in the RFA (Section III.1.A). Eligibility is not limited to academic medical centers. An institution is eligible if it fits the criteria detailed in Section III.1.A of the RFA, including compliance with 42 CFR, Part 50, Subpart F of the Federal Code of Regulations (available at http://grants.nih.gov/grants/compliance/42_cfr_50_subpart_f.htm).

Question C3: Can multiple researchers within an institution submit separate applications with different fields of study?

Answer C3: Eligible institutions (as described in Section III.1.A of the RFA) may submit more than one application to RFA-HS-11-004, provided each application is scientifically distinct. However, AHRQ will not accept similar grant applications with essentially the same research focus from the same applicant organization.

Please note that an applicant to RFA-HS-11-004 may submit a scientifically distinct application to RFA-HS-11-003 for the CERTs Scientific Forum. However, applicants should note that, in contrast to RFA-HS-11-004, an organization may submit only one application to RFA-HS-11-003. For additional clarification and details, read the FAQs for RFA-HS-11-003 at http://www.ahrq.gov/fund/hs110003qa.htm.

D. Partnerships

Question D1: Must applicants partner with one or more existing CERTs sites in their proposed projects?

Answer D1: Applicants are not required to engage in partnerships with existing CERTs. The RFA states that partnerships with individuals and/or organizations engaged in relevant aspects of clinical care or its financing are highly encouraged.

Question D2: What partnerships are appropriate for establishing CERTs Research Centers?

Answer D2: As stated in the RFA, stakeholders and/or partners may represent individuals, organizations, or other entities with compelling therapeutics questions and/or a willingness to put research findings and educational activities into policy and practice; in this regard, CERTs Research Centers are encouraged to form close partnerships with their local and State health care systems. Other partners may include Federal agencies (such as AHRQ, the U.S. Food and Drug Administration, or the Centers for Medicare & Medicaid Services), the Medicaid Medical Directors Learning Network, professional societies, and nonprofit and private organizations. Applicants will be reviewed for the strength of their working relationship and awareness of the needs and priorities of their proposed partners and stakeholders. The review criteria include an assessment of whether the research question, design, or analysis is adequately informed by key partners or stakeholders who are involved in the application of the proposed studies or activities.

Question D3: How can applicants verify a planned Federal partnership if the partner's policies do not allow it to provide an official letter in the application?

Answer D3: This RFA encourages applicants to form or leverage partnerships with their local and State health care systems, as well as other Federal and State agencies, professional societies, and nonprofit and private organizations. The objective of the partnership is to ensure that the proposed research questions reflect the needs of decisionmakers, or that the research findings could be readily adopted or utilized by decisionmakers. The prohibition in Federal regulation (5 C.F.R. § 2635.702) of misuse of position pertains specifically to activities such as letters of recommendation or endorsements of grant applications by Federal personnel. While applicants may not be able to obtain a Federal (or other) partner's documentation of a partnership or other working relationship, applicants should do their best to describe the specifics of the relationship with the best information available and to note the circumstances precluding a letter of support. Subject to the partner's agreement, applicants may be able to include language describing their communications, planned interactions, and agency policy with as much detail and documentation as the agency in question will allow.

Question D4: Can letters of support from stakeholders or partners be included in the appendix to the application?

E. Investigator Qualifications, Titles, and Other Designations

Question E1: What qualifies a senior investigator to be a CERTs Principal Investigator (PI)? Is it years of experience, academic rank, number of publications, or prior research grant experience, such as R01 leadership?

Answer E1: There are no specific guidelines of what qualifies a senior investigator to be a CERTs PI; this determination is made upon review by the Special Emphasis Panel. Applicants should make the best case for their abilities within the application. The RFA clearly describes what the PI must be able to provide in terms of leading these large, complex 5-year grants.

Question E2: Can the investigator who is designated to act and make decisions in the absence of the PI be named a co-PI?

Answer E2: No. AHRQ does not recognize multiple PIs, so the term "co-PI" should not be used. For space considerations and/or convenience, an applicant may designate some other shorthand or abbreviation to refer to the designated co-Investigator; applicants should make sure this and any other abbreviations are explicit and clear.

Question E3: In the RFA it states, "One co-investigator from the RC must be designated in the application to act and make decisions related to SC business or attend SC meetings, in the absence of the PI. The designated co-investigator for the PI will be designated as key personnel." Can more than one co-investigator (listed as key personnel) be empowered to serve/act in the absence of the PI?

Answer E3: Yes. More than one co-investigator from key personnel may be designated in the application to act and make decisions related to Steering Committee (SC) business or attend SC meetings, in the absence of the PI. If designating two or more key personnel to act on behalf of the PD/PI, applicants should describe their approach and provide its rationale. Only one PD/PI may be designated on the application, so if multiple co-investigators are designated, no more than one at any given time should be acting and making decisions related to SC business or meetings.

F. Determining Suitability of the Theme, Projects, or Research Ideas for Submission

Question F1: How can applicants determine if their planned approach is a good fit for this RFA?

Answer F1: Applicants should read the RFA closely, including its review criteria; this is the best available guidance to potential applicants about the responsiveness of their planned research. Applicants should be aware that the determination of suitability and responsiveness of applications is the task of the Special Emphasis Panel, not AHRQ.

Question F2: Can applicants discuss the scientific and research aspects of their proposals with AHRQ?

Answer F2: AHRQ appreciates all expressions of interest from prospective applicants. As stated in answer F1, applicants should read the RFA closely, including its review criteria; this is the best available guidance to potential applicants about the responsiveness of their planned research.

If applicants have specific questions after reviewing the RFA, they can E-mail these questions to CERTsFOA@ahrq.hhs.gov. For reasons of equity and consistency, AHRQ responds in writing to all inquiries. Wherever it is possible and appropriate, AHRQ will clarify common areas of uncertainty in a written and generalized format that is applicable for dissemination to other potential applicants, such as FAQs.

Telephone counseling on potential study ideas is discouraged in order to be equitable and avoid potential misdirection of applicants. Applicants should be aware that the determination of suitability and responsiveness of applications is the task of the Special Emphasis Panel, not AHRQ.

Question F3: Are diagnostic tests and devices within the scope of therapeutics covered by this RFA?

Answer F3: CERTs are authorized by 42 U.S.C. 299b-1(b) to conduct research to provide objective clinical information about drugs, biological products, and devices (therapeutics) and to increase awareness of: 1) new uses of drugs, biological products, and devices, 2) ways to improve the effective use of drugs, biological products, and devices, and 3) risks of new uses or of combinations of drugs and biological products. In addition, CERTs are charged with conducting research to improve the quality of health care while reducing its cost through: 1) the appropriate use of drugs, biological products, or devices, and 2) the prevention of adverse effects and their consequences due to drugs, biological products, and devices. The CERTs mandate also includes the conduct of research on the comparative effectiveness and safety of drugs, biological products, and devices and such other activities as the Secretary of Health and Human Services determines to be appropriate.

Diagnostics often direct the choice and use of multiple therapeutics (drugs, devices, and biological products), and many diagnostics are themselves classified as devices. In general, diagnostics are considered within the CERTs mission. Whether an application dealing with diagnostic tests or devices is a good match for this RFA will depend on the nature of the application and its review by the Special Emphasis Panel.

Question F4: Are all individual projects within CERTs U19 applications required to be new submissions (that is, not already submitted for NIH funding)? For example, if there is an R01 awaiting NIH review, should there be no overlap between the submitted R01 and the proposed project within the CERT U19?

Answer F4: There should be no overlap between other submissions for Federal funding and any component or proposed project within the CERTs U19 application. Like NIH, AHRQ seeks submissions which have significant and substantial differences in content and scope from other submissions to AHRQ, NIH, or other Federal funding agencies. There are no set rules for determining what is substantially similar, but guidance offered by the NIH Center for Scientific Review may be helpful in proposing a project to RFA-HS-11-004 that is related but does not overlap any other open submission for funding. For more information, go to http://cms.csr.nih.gov/ResourcesforApplicants/OverlapEvaluation.htm.

Question F5: Can applicants propose conferences and related activities as one of their three to five projects?

Answer F5: The FOA notes in Section I, under "Proposed Research Projects" and "Additional Guidance," that expert meetings and consensus conferences may be proposed as CERTs project activities. Specifically, the FOA states that a project will usually be a single, large research study or other activity, but may occasionally be divided into a few smaller and interrelated components. An activity is a goal-oriented undertaking that, in contrast to research, is not necessarily hypothesis-driven and may be hypothesis-generating or formative of future research and educational activities. Examples of activities include, but are not limited to, descriptive research, agenda setting, methods development, expert meetings or consensus conferences, and scientific review provided to AHRQ or the CERTs Steering Committee, Scientific Forum, or other Research Centers. The FOA also states that each Research Center should include documentation of any planned partnerships for which the partner contributes substantial resources (e.g., shared publications, conferences).

Question F6: Can applicants propose a collaborative project with another CERTs applicant? How about a collaborative concept brief?

Answer F6: There is no prohibition against proposing a project or concept brief that has been developed in collaboration with another CERTs applicant; however, there are different expectations for projects and concept briefs. Relative to CERTs projects, applicants should note that each application is evaluated independently on its own merits for potential funding, so each of the three to five proposed projects should be able to stand on its own in the event the collaborating institution is unsuccessful. Synergies with another applicant, rather than close interdependence where a proposed project cannot be completed independently by each applicant, are advisable.

Relative to concept briefs, which outline important and common issues in therapeutics that could be addressed by the applicant along with other CERTs Research Centers, there is no assumption that an individual Research Center will conduct these activities in isolation of other Research Centers.

Question F7: What is the definition of a "device" for the purposes of this application?

In brief, the FDA states a device is "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Question F8: Can applicants patent one or more therapeutic products (e.g., a drug, biological product, or device) developed as part of their proposed application?

Answer F8: The CERTs are authorized by 42 U.S.C. 299b-1(b) to examine new, appropriate, and quality uses of drugs, biological products, and devices. The statutory authorization language does not support the development and patenting of new drugs, biological products, or devices as the mission of CERTs. Rather, CERTs are charged to assess the safety, effectiveness, and quality use of existing drugs, biological products, and devices by pursuing innovative research and educational activities. If development and patenting of new medical products are major aims of your application, other commercial funding opportunities are likely to be a better fit than this FOA.

G. Formatting, Organization, and Page Limits of Submissions

Question G1: Does the 25-page limit for the Research Strategy section of the application include the two required concept briefs?

Answer G1: Yes, the two required concept briefs are included in the 25-page limit for the Research Strategy section. Each brief should be a maximum of one page in length; briefs may be shorter as long as they adequately lay out the question/issue, its significance, impact, and potential approach(es) to address the issue using a multi-CERTs working group or committee.

Question G2: Are applications allowed to have appendices?

Answer G2: An application may include an appendix, but applicants should not use the appendix to circumvent the specific page limit for the Research Strategy component. Applicants should observe the page number limits specified in the RFA. An application will be rejected if it does not comply with these requirements.

Question G3: Can letters of support from stakeholders or partners be included in the appendix to the application?

Note correction and update to original response.

Answer G3: No. The original response, posted on May 5, 2011, was in error in stating: "Yes, it is appropriate to include letters of support in the appendix. Applicants should note the special instructions in Section IV.3.B of the FOA for submitting appendices to NIH and AHRQ."

The PHS 398 instructions state that letters of intent should NOT be put in the appendix. Please follow the full PHS 398 instructions, a section of which is excerpted below. We apologize for any inconvenience.

5.5.14 Letters of Support (e.g., Consultants)Provide all appropriate letters of support, including any letters necessary to demonstrate the support of consortium participants and collaborators such as Senior/Key Personnel and Other Significant Contributors included in the grant application. Letters are not required for personnel (such as research assistants) not contributing in a substantive, measurable way to the scientific development or execution of the project. For consultants, letters should include rate/charge for consulting services. Do not place these letters in the Appendix. Consultant biographical sketches should be in the Biographical Sketch section.

Question G4: Does the 25-page limit for the Research Strategy section of the application include the Specific Aims?

A clarification to this answer pertaining to Form Page 2 and Specific Aims appears under Question 8 of this section.

Answer G4: No. On page 2 of Form 398, applicants must state the overall aim(s) or goal(s) of the proposed Research Center and its expected impacts, and also succinctly list the specific objectives of their proposed work, as described in Section IV.6.2 of the FOA. In addition, applicants must note the programmatic interest areas addressed in the application and their specific leadership and contributions in the space allotted on page 2. The Specific Aims are thus limited to one page, and that page is separate from the Research Strategy, and not counted toward the 25-page limit.

In the separate Research Strategy section, applicants may include overarching or project-specific (as opposed to overall) aims and objectives for each of the three to five projects that will be conducted during the entire grant period. These descriptions do not have a page limit, other than the 25 pages allowed for the entire Research Strategy section.

Question G5: Can a smaller font size be used for tables and figures?

Answer G5: Yes. A size smaller than 11 point font may be used for figures, graphs, diagrams, charts, tables, figure legends, and footnotes; however, the font type must follow the font typeface requirement (Palatino, Georgia, Arial, or Helvetica) and be readily legible.

Question G6: Is there a page limit for the appendix?

Answer G6: The FOA does not restrict the number of pages in the appendix, stating only that applicants should not use the appendix to circumvent the page limit of the Research Plan component and warning that an application that does not observe the required page limit may be delayed in the review process. Applicants should note the special instructions in Section IV.3.B of the FOA for submitting appendices to NIH and AHRQ.

Question G7: Are biographical sketches for key personnel required?

Answer G7: As stated in the FOA, it is critical that applicants follow the instructions for the PHS 398 application form (available at http://grants.nih.gov/grants/funding/phs398/phs398.pdf; PDF Help), except where instructed to do otherwise (in either the FOA or a notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (in both the PHS 398 Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide, as well as any program-specific instructions noted in Section IV of the FOA. When program-specific instructions deviate from those in the Application Guide, applicants should follow the program-specific instructions.

Question G8: The PHS 398 instructions about whether the Specific Aims are part of the 25-page limit for the Research Strategy section conflict with an answer provided in the FAQs (Section G Question 4). The answer implies that the 1-page Specific Aims should be included in Form Page 2. Please clarify.

Answer G8: The 1-page Specific Aims is separate from Form Page 2, and the PHS 398 instructions apply. In addition to stating the Project Summary and Relevance, Form Page 2 must also include the required information described in Section IV.6.2 of the RFA.

The 1-page Specific Aims is separate from the 25-page limit for the Research Strategy section. The answer to Section G Question 4 incorrectly implies that the 1-page Specific Aims is the same as the Summary and Relevance section of Form Page 2.

If necessary to capture the detailed aims of each of the three to five required projects, those project-specific aim(s) may be included within the 25-page Research Strategy section, as described in Section G Answer 4.

In summary, applicants should submit:

PHS 398 Form Page 2, as per the PHS 398 and the RFA instructions in Section IV.6.2.

A 1-page Specific Aims.

A Research Strategy section that is no more than 25 pages, which may contain project-specific aim(s) for each of the three to five research projects.

Question G9: In Section IV.6.5 (Composite and Component Budgets) of the RFA, there is a statement that says, "Detailed budgets and budget justifications for each year of support are required within the descriptions of each project and core." Does this mean that each budget and justification should follow each project description and, therefore, will be in the Research Strategy section?

Answer G9: Detailed budgets and budget justifications for each year of support are separate from the Research Strategy section and should not be included in that section or its 25-page limit. AHRQ has no specific guidance on where to place this information beyond what is provided in the PHS 398 instructions.

H. Letters of Intent

Question H1: What specific information should be in the letter of intent? Is there a particular format or length?

Answer H1: As stated in the RFA, the letter of intent allows AHRQ staff to estimate the potential peer review workload and plan the review accordingly (that is, anticipate the nature of reviewer expertise that will be required). Prospective applicants may submit a letter of intent that includes an acknowledgement of interest in this funding opportunity (referring to the number and title of the funding opportunity), a few comments on the subject of the proposed research, background expertise of key personnel, the nature and role of participating institutions, and the name and E-mail address of the PI. This letter of intent is not required, is not binding, and is not considered in the review of a subsequent application. AHRQ requests that letters of intent be E-mailed to CERTsFOA@ahrq.hhs.gov by April 20, 2011.